MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X400MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	32300400S
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Patient had slipped several times from a bicycle pedals and came hard with the affected limb - then the appearance or straining was no longer possible.Radiologically secured nail fracture proximal to the femoral neck screw with the above mentioned product mentioned above.Intraoperative recovery of the implant will take place.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided for investigation.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.More detailed information about the complaint event such as x-rays, patient records and date of implant as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the complaint event, the probable cause can be attributed to patient related issue as the event suggests the patient slipped many a times after surgery.The failure was probably not caused by a deficiency of the product but is rather linked to patient factor.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Patient had slipped several times from a bicycle pedals and came hard with the affected limb - then the appearance or straining was no longer possible.Radiologically secured nail fracture proximal to the femoral neck screw with the above mentioned product mentioned above.Intraoperative recovery of the implant will take place.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X400MM X 130°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8680823
• Report Number: 0009610622-2019-00483
• Device Sequence Number: 14020441
• Product Code: HSB
• UDI-Device Identifier: 07613153313069
• UDI-Public: 07613153313069
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 32300400S
• Device Lot Number: K0B88FF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention